Methods and systems for holding surgical instrument count sheets

ABSTRACT

The disclosure includes systems and methods for hospital based sterilization of surgical instruments. An exemplary system includes a wrapped sterilization tray or container defining at least one opening to permit a sterilant to pass therethrough and least one surgical instrument disposed in the sterilization tray. The system still further includes a count sheet holder disposed on the sterilization wrap or container. The count sheet holder defines a compartment for receiving a count sheet and means for attaching the count sheet holder to the sterilization container or wrapped tray.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority to U.S.Provisional Patent Application No. 61/360,975, filed Jul. 2, 2010. Theaforementioned patent application is incorporated by reference herein inits entirety.

BACKGROUND

1. Field of the Disclosure

The present disclosure relates to methods and systems for sterilizingsurgical instruments and related equipment. Particularly, the presentdisclosure is directed to improved systems and methods for sterilizationby sequestering count sheets in locations that are easily accessible tohospital personnel.

2. Description of Related Art

Open top surgical trays are conventionally wrapped in a sterilizationwrap which is generally a non-woven fabric (but can be a woven textilefabric) with surgical instruments inside to form what is typicallyreferred to as a sterilization pack. By way of further example, a rigidsterilization container with a lid may also be used, sometimes referredto as a container. Such containers are generally rigid and are notwrapped The sterilant penetrates the container through a filter on thelid, and this filter also serves as a sterile barrier. Once asterilization pack or container has completed a sterilization cycle, itmay be removed from the sterilizer and stored for future use duringsurgery.

Surgical instrument trays and containers are generally sterilized usingsteam or another gas. This gas is commonly referred to as the sterilant.The contents of the tray or container, such as surgical instruments, aresterilized by way of the sterilant gas contacting and sterilizing theinstruments. Sterilization of surgical tools including scalpels,scissors and clamps may be thus accomplished in a known manner byplacing the tools in a sterilization tray (or container), wrapping thetray with a sterilization wrap to form a sterilization pack and thenplacing the pack or container into a sterilizer.

Persons have recognized that count sheets can cause problems insterilization. Count sheets, sometimes referred to as inventory sheets,surgical instrument count sheets and the like, are sheets of paper (suchas 8.5×11 inch sheets of paper) that are printed out in hospitalsterilization departments that list the contents of each wrappedsterilization tray or container.

Count sheets sometimes accompany instruments in the sterilization trayor container. While these sheets are sterilized with the surgicalinstruments in the tray under such circumstances, ink and other chemicalcontaminants from the count sheet can be deposited on the contents ofthe tray, including surgical instruments. In addition, paper materialfrom the count sheet can also be deposited on the instruments. Either ofthese conditions is in contravention to certain aspects of the AAMIstandards and the AORN Recommended Practices, which are incorporatedherein by reference in their entireties. This can result in toxicchemical contamination or other contamination, possibly endangering thehealth and safety of the patient. While those of skill in the art canattempt to remedy this situation by placing the count sheet in packagingsuch as a paper bag, peel pack or the like within the sterilization packor container, this still requires the package to be opened to confirmthe contents of the container, which simultaneously compromises thesterility of the instruments, possibly requiring re-sterilization.

It has also been standard practice to attempt to attach count sheets tothe exterior of sterilization containers and wrapped sterilizationpacks. With respect to containers, some have stapled the count sheetitself around a handle of the container and run both through asterilization cycle. This can unduly damage the count sheet, to saynothing of possibly introducing one or more staples into the OR that maynot be noticed and accounted for. Similarly, some have tried to tape thecount sheet directly to the sterilization wrap. This can damage thecount sheet, but removal of the tape from the wrap can tear the wrap,compromising sterility of the sterilization pack, thereby requiringre-sterilization. Some have attempted to tape count sheets tosterilization wraps inside of paper bags, but this presents the sameproblem with tearing the wrap, and presents the additional disadvantageof not being able to view the count sheet in any respect without tearingthe bag and removing the count sheet from the bag.

Some have tried to place count sheets in what are commonly referred toas “peel packs”, which include a transparent plastic film on abreathable paper backing. The peel pack is then attached typically tothe wrap of a sterilization pack with tape. However, this can lead to anumber of problems. First, it should be noted that the peel pack istypically placed with the transparent side up, thereby possiblypreventing sterilant from infiltrating the peel pack, thereby possiblypreventing sterilization of the count sheet. This can lead to a sense offalse security of sterility of the count sheet. If the peel pack islater opened in the sterile field of the Operating Room (“OR”), thesterile field is compromised, thereby jeopardizing the procedure, thepatient, and/or generally resulting in delaying the procedure until thesterile field can be reestablished, which typically requires allinstruments in the tray to be re-sterilized. Use of the peel pack isalso inconvenience because it requires tape to be peeled off of the wrapof the sterilization pack, which can tear a hole in the wrap, andcompromise the sterility of the pack once sterilized.

As will be appreciated from the above discussion, the approaches presentin the art are inadequate for a variety of reasons. The presentdisclosure provides a solution for these problems.

SUMMARY OF THE DISCLOSURE

The purpose and advantages of the present disclosure will be set forthin and become apparent from the description that follows. Additionaladvantages of the disclosed embodiments will be realized and attained bythe methods and systems particularly pointed out in the writtendescription hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosure, as embodied herein, in one aspect, the disclosureincludes a system for hospital based sterilization of surgicalinstruments. The system includes a sterilization tray defining at leastone opening to permit a sterilant to pass therethrough and a pluralityof sides, wherein the bottom and plurality of sides cooperate to definea compartment for receiving surgical instruments to be sterilized. Thesystem further includes at least one surgical instrument disposed in thesterilization tray, a sterilization wrap wrapped around thesterilization tray, the sterilization wrap being made from a breathablematerial adapted and configured to permit sterilant to pass through thewrap and through the tray, and a count sheet including a listingdescribing the at least one surgical instrument disposed in thesterilization tray. The system still further includes a pouch-shapedcount sheet holder disposed on the sterilization wrap. The count sheetholder includes a first sheet of material, a second sheet of materialdisposed on and attached to the first sheet of material proximate theperimeter of the first and second sheets to define an elongate openingproximate a peripheral edge of the first sheet of material of the countsheet holder. The opening is in communication with a generallyrectangular compartment defined between the first and second sheets ofmaterial for receiving the count sheet. The count sheet holder furtherincludes a fastener for attaching the count sheet holder to thesterilization wrap.

In another aspect, a peripheral edge of the second sheet of material canextend beyond the peripheral edge of the first sheet of material to forman overhang, such that the elongate opening proximate the peripheraledge of the first sheet of material of the count sheet holder is locatedbehind the second sheet of material. If desired, the overhang caninclude adhesive disposed on an inner face of the overhang, and may becovered with a removable covering that can be removed to expose theadhesive, such that the adhesive, when exposed, causes the overhangadhere to the sterilization wrap when pressed against the wrap after thecount sheet is inserted in the count sheet holder, thereby preventingaccess to the count sheet. Preferably, the count sheet holder thenfurther includes a removable tamper evident strip that, when removed,provides access to the count sheet and visual indication that the countsheet holder has been compromised.

In accordance with a further aspect, the fastener can be applied to anoutwardly disposed face of the first sheet of material. The fastenerpreferably includes pressure sensitive adhesive applied to the outwardlydisposed face of the first sheet of material. The count sheet holder canfurther include a removable protective layer of material disposed on topof the pressure sensitive adhesive. In another embodiment, when thesterilization wrap comprises a non-woven material, the fastener caninclude a plurality of hooks adapted and configured to mate directlywith the non-woven material of the wrap to hold the count sheet holderin place.

In accordance with another embodiment, the perimeter of each of thefirst and second sheets defines four peripheral sides, wherein the firstlayer and second layer of material are joined about their periphery atthree of the four sides, such as by a heat seal, an ultrasonic weld,adhesive, and the like. In one embodiment, the count sheet holder can beformed from a single folded sheet of material that is joined on twoparallel sides by a seal, wherein the two parallel sides are separatedby a third side formed by a fold line. Preferably, the first sheet ofmaterial is at least partially transparent to permit the contents of thegenerally rectangular compartment of the count sheet holder to be viewedfrom outside the count sheet holder when the count sheet holder ismounted on the sterilization wrap.

In a further aspect, the count sheet holder preferably includes indiciathereon to inform a user of the count sheet holder that the count sheetis not to be considered to be sterile so as to avoid contamination ofthe sterile field of an operating room. In another embodiment, aperipheral edge of the second sheet of material of the count sheetholder extends beyond the peripheral edge of the first sheet of materialto form a foldable flap adapted and configured to be folded over theelongate opening. The fastener can accordingly be applied to anoutwardly disposed face of the second sheet of material. In anotherembodiment, the count sheet holder can include a zipper closure disposedproximate the elongate opening for facilitating closure of the countsheet holder. In one embodiment, the count sheet holder can includematerial that permits writing thereon. The first and second sheets ofthe count sheet holder can be comprised of polypropylene and/or othersuitable materials, such as paper. The fastener can include an adhesivethat in turn includes acrylic copolymer.

In accordance with further aspects, the count sheet holder can bedisposable or reusable. For example, the count sheet holder can beadapted and configured to be reused in a plurality of sterilizationcycles. If desired, the sterilization wrap can include a textile fabricor a melt blown spun bonded polypropylene sterilization wrap.

The disclosure further provides a method of sterilizing surgicalinstruments in a hospital sterilization department. The method includesproviding a sterilization tray defining at least one hole therethroughto permit a sterilant to pass therethrough and a plurality of sides,wherein the bottom and plurality of sides cooperate to define acompartment for receiving surgical instruments to be sterilized. Themethod further includes disposing at least one surgical instrument inthe sterilization tray and wrapping a sterilization wrap around thesterilization tray. The sterilization wrap is made from a breathablematerial adapted and configured to permit sterilant to pass through thewrap and through the tray. The method still further includes providing acount sheet including a listing describing the at least one surgicalinstrument disposed in the sterilization tray, and disposing apouch-shaped count sheet holder on the sterilization wrap. The countsheet holder includes a first sheet of material, a second sheet ofmaterial disposed on and attached to the first sheet of materialproximate the perimeter of the first and second sheets to define anelongate opening proximate a peripheral edge of the first sheet ofmaterial of the count sheet holder. The opening is preferably incommunication with a generally rectangular compartment defined betweenthe first and second sheets of material for receiving the count sheet.The count sheet holder further includes a fastener for attaching thecount sheet holder to the sterilization wrap, and disposing the countsheet in the count sheet holder to form a sterilization package. Themethod further includes the step of sterilizing the sterilizationpackage until the at least one surgical instrument is sterilized.

In accordance with further aspects of the method, the count sheet holdercan be applied prior to or after the sterilizing step, as desired. Thesterilant can be steam, plasma, hydrogen peroxide or ozone. In anotheraspect, the count sheet can be made from a cellulose-based material ornon-cellulose based material. If desired, the count sheet holder can bedisposed after the sterilization step, or can be reused in a subsequentsterilization operation.

The disclosure further provides a system for hospital basedsterilization of surgical instruments for sterilization containers. Thesystem includes a sterilization container having a bottom portion and atop portion, at least one of the bottom portion and the top portiondefining at least one hole therethrough to permit a sterilant to passtherethrough, wherein the bottom portion and top portion cooperate todefine an interior compartment for receiving surgical instruments to besterilized. The system further includes at least one surgical instrumentdisposed in the sterilization container, and a count sheet including alisting describing the at least one surgical instrument disposed in thesterilization container. The system also includes a count sheet holderdisposed on the sterilization container. The count sheet holder includesa cover portion, a body portion, a hinge attaching the cover portion tothe body portion, wherein the body portion and cover portion cooperateto define a compartment for containing a count sheet when the cover isclosed, and a fastener for fastening the count sheet holder to thesterilization container.

In accordance with a further aspect, the cover portion of the countsheet holder can include a front face, a back face, and a perimeter beadthat is received by a complementary bead defined in body portion. Thecount sheet holder can further include at least one outwardly extendingtab on at least one of the cover portion and body portion to facilitateopening or closure of the count sheet holder. If desired, the countsheet holder can further include at least one vent to permit air orother gas to be evacuated from the compartment. In one aspect, the countsheet holder can include an interlocking bead along two parallel sidesof the count sheet holder. The fastener of the count sheet holder caninclude a hook and loop fastener for removably attaching the count sheetholder to the sterilization container. In one embodiment, the fastenerof the count sheet holder includes a foam tape for removably attachingthe count sheet holder to the sterilization container, preferably anacrylic foam type, such as VHB™ foam tapes, commercially available fromThe Minnesota Mining & Manufacturing Co. (“3M”) of St. Paul, Minn.

Preferably, the sterilization container includes at least one handle orlatch and the fastener of the count sheet holder includes a strapextending from the count sheet holder for attaching to the handle orlatch of the sterilization container. The strap can include a tiplocated at a distal end of the strap having at least one barb forengaging an opening defined in the strap. The opening can have anydesired shape, such as a straight, curve or cross-shape. If desired, thecount sheet holder can include a snap closure (e.g., using aninterference fit) to maintain the count sheet holder in a closedcondition. The count sheet holder can be made from a variety ofmaterials, such as polypropylene, polyethylene terephthalate orsilicone, among others. Preferably, the count sheet holder is at leastpartially transparent to permit the contents of the count sheet holderto be viewed from outside the count sheet holder when the count sheetholder is mounted on the sterilization container. The count sheet holdercan include indicia thereon to inform a user of the count sheet holderas to proper use of the count sheet holder. The count sheet holder canbe disposable, or be adapted and configured to be reused in a pluralityof sterilization cycles.

The disclosure further provides a method for sterilizing surgicalinstruments in a hospital. The method includes providing a sterilizationcontainer having a bottom portion and a top portion, at least one of thebottom portion and the top portion defining at least one opening topermit a sterilant to pass therethrough, wherein the bottom portion andtop portion cooperate to define an interior compartment for receivingsurgical instruments to be sterilized. The method further includesdisposing at least one surgical instrument in the sterilizationcontainer and providing a count sheet including a listing describing theat least one surgical instrument disposed in the sterilizationcontainer. The method also includes disposing a count sheet holder onthe outside of the sterilization container. The count sheet holder has abody portion defining a compartment for containing a count sheet. Themethod further includes the steps of disposing the count sheet in thecount sheet holder to form a sterilization package, and sterilizing thesterilization package until the at least one surgical instrument issterilized.

In accordance with further aspects of the method, the count sheet holdercan further include a cover portion, a hinge attaching the cover portionto the body portion, wherein the body portion and cover portioncooperate to define the compartment for containing a count sheet whenthe cover is closed, and a fastener a for fastening the count sheetholder to the sterilization container. The count sheet holder can beapplied prior to, or after, the sterilizing step. The sterilant can besteam, plasma, hydrogen peroxide or ozone. The count sheet can be madefrom a cellulose-based material or non-cellulose based material, such asspun bonded polypropylene, sold under the trade name of Tyvek®. Thecount sheet holder can be disposed after the sterilization step, orreused in a subsequent sterilization operation.

In accordance with still further aspects of the method, thesterilization container can include at least one handle, the fastener ofthe count sheet holder can include a strap extending from the countsheet holder for attaching to the handle of the sterilization container,and the disposing step can include directing the strap of the fastenerof the count sheet holder around the handle of the sterilizationcontainer to attach the count sheet holder to the sterilizationcontainer. If desired, the body of the count sheet holder can include anelongate tube closed on a first end and open on the second end. Thecount sheet holder can accordingly further include a cover portionadapted and configured to attach to the second end of the body portionand a fastener a for fastening the count sheet holder to thesterilization container. The elongate tube can have a rounded,rectangular or hexagonal cross-section. The count sheet holder canfurther include a hinge attaching the cover portion to the body portion,wherein the body portion and cover portion cooperate to define thecompartment for containing a count sheet when the cover is closed.

If desired, the step of disposing the count sheet in the count sheetholder can include rolling the count sheet holder into a cylindricalshape prior to inserting the count sheet into the body portion of thecount sheet holder. Disposing a count sheet holder on the outside of thesterilization container can include attaching the count sheet holder tothe container using a strap, a hook and loop fastener and/or anadhesive, among other means.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the embodiments disclosed herein.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the method and system of the disclosure. Together withthe description, the drawings serve to explain the principles of thedisclosed embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1(A) is an isometric view of a first representative embodiment of acount sheet holder in accordance with the present disclosure.

FIG. 1(B) is an isometric view of a second representative embodiment ofa count sheet holder in accordance with the present disclosure.

FIG. 2 is an isometric view of a wrapped instrument set including anembodiment of a count sheet holder in accordance with the presentdisclosure.

FIG. 3 is an isometric view of a sterilization container including anembodiment of a count sheet holder in accordance with the presentdisclosure.

FIG. 4 is an isometric view of a sterilization container including afurther embodiment of a count sheet holder in accordance with thepresent disclosure.

FIGS. 5-10 are various views of a further representative embodiment of acount sheet holder in accordance with the present disclosure.

FIG. 11 is a view of another representative embodiment of a count sheetholder in accordance with the present disclosure.

FIGS. 12-14 are various views of yet another representative embodimentof a count sheet holder in accordance with the present disclosure.

FIG. 15 presents various views of an alternative embodiment of a countsheet holder including parallel longitudinal engagement surfaces.

FIG. 16 illustrates another embodiment of a count sheet holder inaccordance with the present disclosure.

DETAILED DESCRIPTION

Reference will now be made in detail to the present preferredembodiments of the disclosure, examples of which are illustrated in theaccompanying drawings. The methods and corresponding steps of thedisclosed embodiments will be described in conjunction with the detaileddescription of the systems.

The deficiencies in the art are set forth above. Applicants haveinvented new ways of addressing these problems, as embodied herein. Inone aspect, the disclosure provides methods of providing a count sheet,securing the count sheet in a protective count sheet holder that definesan enclosure, and securing the count sheet holder to a wrappedsterilization tray or instrument container, and sterilizing tray orcontainer. The enclosure is adapted and configured to protect the countsheet, but the count sheet is easily removable post-sterilization, thusdecreasing the chances that the sterility of the wrapped tray or thecontainer will be compromised. Thus, the sterility of the package ismaintained while permitting access to the count sheet aftersterilization, yet the sterility of the surgical instruments or othertray/container contents is not compromised. The enclosure is preferablysufficiently durable to survive the sterilization process, and should beable to protect and contain the count sheet during sterilization, andduring the trip from the sterilization department of the hospital to theoperating room (“O.R.”). Preferably, the enclosure includes a variety ofindicia including, for example, instructions for use and an indicationthat the contents of the enclosure are not sterile. This can beimplemented in a variety of ways.

In accordance with one embodiment, a count sheet holder including anenclosure is provided for a count sheet that can be used with a wrappedsterilization tray or a container. For purposes of illustration, and notlimitation, an exemplary count sheet holder 100 is illustrated in FIGS.1-3. As illustrated in FIG. 1(A), count sheet holder 100 is provided inthe form of a pouch formed from a first layer 110 of material disposedon a base, or second layer of material 120. If desired, the second layer120 of material can include adhesive on its back side 122 that may beexposed by removing a further protective layer 130. As illustrated,first layer 110 and second layer 120 are joined about three of foursides in a bonding region 114 by various means (e.g., heat sealing,adhesive, solvent welding, ultrasound welding, etc.) and defining agenerally rectangular compartment 118 therein and leaving an elongateopening 112 along one edge to permit a count sheet 170 to be insertedinto the compartment 118 of the count sheet holder 100. Indicia 116 ofvarious types may be provided to facilitate proper use of the enclosure100. Preferably, indicia 117 of non-sterility of the count sheet is alsoprovided to inform hospital personnel that the count sheet is not to beconsidered to be sterile, thereby minimizing the chances that thesterile field in the OR will be compromised by the count sheet. Ifdesired, a foldable flap (shown in dashed lines as 143 with an adhesivepatch 144) can be provided to fold over opening 112 after the countsheet is inserted. By way of another example, a zipper closure(notshown) can be provided along opening 112 to maintain count sheet holder100 in a closed condition.

As further illustrated in FIG. 1(B), an alternative count sheet holder100′ is provided in the form of a pouch formed from a first layer 110′of material disposed on a base, or second layer of material 120′. Ifdesired, the second layer 120′ of material can include adhesive on itsback side 122′ that may be exposed by removing a further protectivelayer 130′. As illustrated, first layer 110′ and second layer 120′ arejoined about three of four sides in a bonding region 114′ by variousmeans (e.g., heat sealing, adhesive, solvent welding, ultrasoundwelding, etc.) and defining a generally rectangular compartment 118′therein and leaving an elongate opening 112′ along one edge to permit acount sheet 170′ to be inserted into the compartment 118′ of the countsheet holder 100′ along the direction of arrow “A”. Indicia 116′ ofvarious types may be provided to facilitate proper use of the enclosure100′. As illustrated, an overhang 145 of the top layer 110′ is providedto protect the edge of the count sheet 170′, and to facilitate the easyremoval of the count sheet from the holder 100′. If desired, theoverhang 145 can include adhesive disposed on an inner face 145 a of theoverhang, and may be covered with a removable covering 145 b that can beremoved to expose the adhesive, such that the adhesive, when exposed,causes the overhang adhere to the sterilization wrap when pressedagainst the wrap after the count sheet is inserted in the count sheetholder, thereby preventing access to the count sheet. Preferably, thecount sheet holder then further includes a removable tamper evidentstrip 179 that, when removed, provides access to the count sheet andvisual indication that the count sheet holder has been compromised.Alternatively, strip 179 can be a zipper closure that can permitselective opening and closing of the count sheet holder. In oneembodiment, the count sheet holder can include material that permitswriting thereon. The count sheet holder can use an adhesive such as aacrylic copolymer to attach it to a wrapped tray or a sterilizationcontainer.

After the adhesive is exposed, the count sheet holder 100 may beattached to the sterilization wrap of a package as illustrated in FIG. 2or directly to the body of a sterilization container as illustrated inFIG. 3. As illustrated in FIG. 2, a sterilization tray is depictedwrapped in a KimGuard® type sterilization wrap, wherein a corner 152 ofthe wrap 150 is wrapped and tucked underneath the package. While notpreferred, enclosure could be provided with an elongate member, cord, ortape 119 that can be wrapped into the sterilization wrap to secure theenclosure to the package, but still leaving the body of the count sheetholder exposed and visible.

By way of further example, in contrast to a wrapped set, a container 160is illustrated in FIG. 3 having a bottom portion 162 for receiving aplurality of instruments and a removable cover portion 164 formaintaining closure of the container. While not preferred, an adhesivebacked count sheet holder 100 can be used in connection with a containeras illustrated in FIG. 3, but preferably a count sheet holder similar toembodiment 200 is used, described in detail below.

Count sheet holder 100, 100′ can be made in a variety of ways and from avariety of materials. Preferably, count sheet holder 100 is made from ahighly durable material that can withstand the conditions ofsterilization (e.g., high humidity and 275° F. for about twenty minutes,with a total cycle time of about an hour including heat up and cooldown), and handling from the sterilization department of a hospital tothe O.R. For example, count sheet holder 100 can be made from layers ofpolypropylene (“PP”), paper, TYVEK® type sheet material, and the like.If adhesive is used to secure the count sheet holder 100 to asterilization wrap or tray, various types of adhesive can be used,including acrylic copolymer, hot melt adhesive, and the like. Countsheet holder 100 can be provided in a variety of shapes, such as squareor elongate and rectangular. As to dimensions, enclosure is preferablyabout 4.75 by about 3.25 inches overall, although other dimensions maybe used as a matter of preference. The material of count sheet holder100 preferably permits writing thereon (such as with permanent marker).For steam sterilization, count sheet holder 100 is preferably appliedprior to sterilization. For plasma, hydrogen peroxide or ozonesterilization, count sheet holder 100 is preferably affixedpost-sterilization, as paper material inside enclosure may cause thesterilization unit to abort, particularly if an adhesive or zipperclosure is not used. When a wrapped container is delivered to the O.R.,the circulating nurse preferably removes the count sheet 170 from thecount sheet holder count sheet holder 100 rather than removing theenclosure from the wrap 150, as the wrap 150 could be torn in theprocess, thereby compromising the sterility of the contents of thesterilization tray. However, it will be appreciated that count sheetholder can nonetheless be applied and filled with count sheet holderbefore or after sterilization, as desired. The count sheet can be madefrom a cellulose-based material or non-cellulose based material, such asspun bonded polypropylene, sold under the trade name of Tyvek®. Anycount sheet holder described herein can be disposed after thesterilization step, or reused in a subsequent sterilization operation.

A second embodiment of a count sheet holder is illustrated in FIGS.4-10, which is preferably configured for use with a sterilizationcontainer, rather than a wrapped sterilization tray. As illustrated inFIG. 4, count sheet holder 200 is provided that is configured to attachto a handle 166 of a container 160. The particular configuration ofcount sheet holder 200 is illustrated in FIGS. 5-10. As can be seen,count sheet holder 200 includes a cover portion 210 attached to a bodyportion 220 by a hinge member 230 that cooperate to define an enclosure240 for containing a count sheet 170. Cover portion 210 includes a frontface 208, a back face 212, and a perimeter bead 214 that is received bya complementary bead 224 in body portion 220, more clearly illustratedin FIG. 10. It will be appreciated that other types of suitable closurescan be used. A plurality of vents 218 are provided to permit air orother gas to be evacuated from compartment 240. One or more tabs 216 canbe provided to facilitate opening count sheet holder 200 aftersterilization, and can also act to hold the enclosure closed if suitablyconfigured, such as with a buckle or the like.

A zip tie, elastic loop or further attachment strap can be used toattach count sheet holder 200 to tray 160. For example, a strap withhook and loop fastener can be provided to selectively attach to holder200 and to a handle 166 of a container 160. Alternatively, an attachmenttab 250 can be provided for attaching holder 200 to a sterilizationcontainer, wherein a tip 252 is provided at a distal end of tab 250having a plurality of barbs 254 for engaging opening 256 in tab aftertab 250 is wrapped, for example, about the handle 166 of container 160.FIG. 7 illustrates back 228 of body portion and FIG. 8 illustrates oneof the vents 218. FIG. 9 is a cross-sectional view illustratingenclosure/compartment 240. Count sheet holder 200 can be made from avariety of materials, including silicone rubber and other materials suchas a thermoplastic elastomer or polypropylene. Count sheet holder 200 ispreferably of dimensions of about 3.25 inches by about 2.5 inchesoverall, such that holder 200 is suitable to contain a 8½ by 11 inchsheet of paper folded into a smaller size. It will be appreciated thatcount sheet holder 200 is preferably reusable, whereas count sheetholder 100 is preferably a disposable item that is disposed with thesterilization wrap.

A further embodiment of a count sheet holder 300 is illustrated in FIG.11. Count sheet holder 300 is a generally envelope-like structure madefrom a preferably transparent first layer 310 bonded to a preferablytransparent second layer 320 via a peripheral seal 314 defining anopening 312 for receiving a count sheet 170. Indicia relating to use 316and non-sterility of the count sheet 317 can also be provided. A strap360 is routed through two openings 350 after insertion of the countsheet and used to attach the holder 300 to the handle 166 of asterilization container 160. Holder 300 can be made from a variety ofmaterials and manners as described with respect to embodiments 100,100′, which are preferably disposable and 200, which is preferablyreusable. Accordingly, holder 300 may be configured to be disposable orreusable. If desired, strap 360 can be unitary with the holder 300wherein the strap 360 can be routed around the handle, through openings350, and then attached either to itself or another portion of holder300.

For purposes of further illustration, and not limitation, FIGS. 12-14present a further representative embodiment of a count sheet holder 400in accordance with the present disclosure. Count sheet holder 400, asillustrated, is a generally rigid reclosable box. FIGS. 12-13 illustratecount sheet holder 400 in an open condition, while FIG. 14 illustratescount sheet holder in a closed condition.

As illustrated, count sheet holder 400 includes a cover portion 420attached to a body portion 410 by a hinge 425 that attaches the coverportion to the body portion. The body portion 410 and cover portion 420cooperate to define a compartment 430 for containing a count sheet(e.g., 475, FIG. 14(D)) when the cover is closed, and a fastener 440 forfastening the count sheet holder to a sterilization container (e.g.,160). FIG. 12(A) illustrates a plan view of the count sheet holder in anopen condition illustrating the exterior planar surfaces 412, 422 of thecover portion 420 and base portion 410 of the count sheet holder 400.FIG. 12(B) illustrates a top view of the count sheet holder,particularly illustrating longitudinal edge walls 414, 424 of the baseportion 410 and cover portion 420, respectively. FIG. 12(C) illustratesa side view of the count sheet holder of FIG. 12(A), illustrating a sideview of strap 440 (discussed below) and lateral edge walls 416, 426 ofthe base portion 410 and cover portion 420, respectively.

The fastener for attaching the count sheet holder 400 to a sterilizationcontainer can comprise a strap 440 having a tip 445 located at a distalend 442 of the strap 440 having at least one barb 446 for engaging anopening 448 defined in the strap 440. As illustrated in FIG. 12(A),opening 448 is located in a proximal region 444 of the strap 440proximate the body, or base portion 410 of count sheet holder. Theopening 440 can have any desired shape, such as a straight, curved orcross-shaped. The particular illustrated shape is a cross shape, asillustrated in FIG. 13(F). The fastener of the count sheet holder canalternatively include a hook and loop fastener and/or adhesive tape 441(FIG. 12(A)) for removably attaching the count sheet holder to thesterilization container. In one embodiment, the fastener of the countsheet holder includes a foam tape for removably attaching the countsheet holder to the sterilization container, preferably an acrylic foamtype, such as VHB™ foam tapes, commercially available from The MinnesotaMining & Manufacturing Co. (“3M”) of St. Paul, Minn.

In accordance with a further aspect, the count sheet holder can includea snap closure 450 (e.g., using an interference fit) to maintain thecount sheet holder in a closed condition. As illustrated in FIG. 14(E),base portion 410 includes a raised bead 456 along the upper outer edgeof wall 416 that interfits with inwardly facing bead 458 that traversesthe inner edge of wall 426. As such, when container is closed, beads 456and 458 slide past each other while walls 416, 426 deform inwardly andoutwardly, respectively until the beads snap into place, holding countsheet holder 400 closed. If desired, outwardly extending tabs 452, 454can be provided so as to provide a means for a user to open count sheetholder 400 to retrieve count sheet 475 from within. If desired, thecount sheet holder 400 can further include at least one vent 462 (FIG.14(A) in any desired location to permit air or other gas to be evacuatedfrom or introduced into the compartment 430.

By way of further illustration, FIG. 14(F) illustrates a perspectiveview of count sheet holder 400 in a closed condition illustrating coverportion 420 and strap 440 as well as indicia 490. FIG. 14(G) illustratesa perspective view of count sheet holder 400 in a closed conditionillustrating base portion 410 and strap 440 as well as opening tabs 454as well as side wall 414 and outer face 412 of base portion. FIGS.14(H)-14(I) are perspective depictions of count sheet holder 400 in anopen condition illustrating the inner and outer surfaces of coverportion 420 and base portion 410, as well as strap 440, hinge 425, walls414, 416 and 424 as well as indicia 490 and tabs 452, 454.

FIGS. 14(J)-14(M) illustrate views of an alternative embodiment of countsheet holder 400′ that is the same as embodiment 400, but insteadreplaces strap 440 with adhesive patches 441 that include hook and loopfastener. Protective backing 441 a is removed from patches 441 to permitcount sheet holder 400′ to be attached, for example, to the wall or topof a sterilization container (preferably in a region with no holes inthe container so as to not obstruct the passage of fluid therethrough).Count sheet holder 400′ can then be removed and reattached as desired byway of the hook and loop fasteners.

In another alternative embodiment, as set forth in FIG. 15, a countsheet holder 500 is provided that is essentially the same as count sheetholder 400, but that further includes an interlocking bead 515 along twolongitudinal parallel sides of the count sheet holder. Specifically,FIG. 15(A) sets forth a plan view of count sheet holder 500 in a closedcondition, wherein reference numerals parallel those of count sheetholder 400. FIG. 15(B) sets forth a sectional view along line A-A ofcount sheet holder 500 in FIG. 15(A), wherein the base portion 510 ofthe count sheet holder is interfitted with cover portion 520 by way ofinterlocking beads 515 a, 515 b. FIG. 15(C) sets forth an enlargeddetail of the interfitting beads, which interfit in the same manner asbeads 456, 458 of embodiment 400. It will be understood that suchoverlapping interfitting beads can be used around the entire perimeterof count sheet holders 400, 500, or around part of the perimeter in acontinuous or interrupted (e.g., dashed) format.

FIG. 16 sets forth still a further exemplary embodiment 600 of a countsheet holder in accordance with the disclosure. Count sheet holder 600is formed by an elongate tubular member 610 that defines an elongatecompartment 620 therein. A cap 630 is further provided for mating withmember 610 to define a closed compartment for receiving a rolled-upcount sheet 675. A hinge 650 can be provided to provide registration tohelp close count sheet holder 600, or components 610, 630 can beseparate. Alternatively, components 610, 620 can be joined by a tether660 that can be routed around the handle of a sterilization containerprior to joining cap 630 to member 610, thus simultaneously providing ameans for attaching the count sheet holder 600 to a sterilizationcontainer. Preferably, a tether or strap 640 is provided that isattached at a first end 644 to member 610 and includes one or more hookand loop fastener or adhesive patches 646 to facilitate attachment ofcount sheet holder 600 to a sterilization container. Count sheet holder600 can have a round cross-section, as shown, or any other desiredshape, such as rectangular, elliptical, hexagonal, and the like.

Cap 630 can be attached to member 610 by any desired means, including aninterference fit by closely matching the outer diameter of member 610with the inner diameter 630 of cap, or by way of screw threads on capand member 610 (not shown) or by way of a snap fit, wherein interiorfacing bosses 652 on the inside of cap snap over a continuous orintermittent boss 654 on open end 612 of member 610, opposite from theclosed end 614 of member 610.

The count sheet holder 400, 500, 600 can be made from a variety ofmaterials, such as polypropylene, polyethylene terephthalate, silicone,aluminum, tin, steel, nylon, other polymers and the like. Preferably,the count sheet holders described herein are at least partiallytransparent to permit the contents of the count sheet holder to beviewed from outside the count sheet holder when the count sheet holderis mounted on the sterilization container or wrapped set. The countsheet holders 400, 500, 600 can include indicia 490, 590, 690 thereon toinform a user of the count sheet holder as to proper use of the countsheet holder as described above. The count sheet holder can bedisposable, or be adapted and configured to be reused in a plurality ofsterilization cycles.

It will be appreciated that the disclosed exemplary count sheet holderssecurely hold count sheets outside of the sterile barrier of thesterilization tray, thereby shielding instruments and trays from foreignparticles arising from the count sheets. It will be apparent to thoseskilled in the art that various modifications and variations can be madein the device and method of the present disclosure without departingfrom the spirit or scope of the disclosure. Thus, it is intended thatthe present disclosure include modifications and variations that arewithin the scope of the subject disclosure and equivalents.

1. A system for hospital based sterilization of surgical instruments,comprising: a) a sterilization tray defining at least one opening topermit a sterilant to pass therethrough and a plurality of sides,wherein the bottom and plurality of sides cooperate to define acompartment for receiving surgical instruments to be sterilized; b) atleast one surgical instrument disposed in the sterilization tray; c) asterilization wrap wrapped around the sterilization tray, thesterilization wrap being made from a breathable material adapted andconfigured to permit sterilant to pass through the wrap and through thetray; d) a count sheet including a listing describing the at least onesurgical instrument disposed in the sterilization tray; and e) apouch-shaped count sheet holder disposed on the sterilization wrap, thecount sheet holder including: i) a first sheet of material; ii) a secondsheet of material disposed on and attached to the first sheet ofmaterial proximate the perimeter of the first and second sheets todefine an elongate opening proximate a peripheral edge of the firstsheet of material of the count sheet holder, wherein the opening is incommunication with a generally rectangular compartment defined betweenthe first and second sheets of material for receiving the count sheet;and iii) a fastener for attaching the count sheet holder to thesterilization wrap.
 2. The system of claim 1, wherein the fastener isapplied to an outwardly disposed face of the first sheet of material. 3.The system of claim 2, wherein a peripheral edge of the second sheet ofmaterial extends beyond the peripheral edge of the first sheet ofmaterial to form an overhang, such that the elongate opening proximatethe peripheral edge of the first sheet of material of the count sheetholder is located behind the second sheet of material.
 4. The system ofclaim 3, wherein the overhang includes adhesive disposed on an innerface of the overhang such that the adhesive causes the overhang adhereto the sterilization wrap when pressed against the wrap after the countsheet is inserted in the count sheet holder, thereby preventing accessto the count sheet.
 5. The system of claim 4, wherein the count sheetholder further includes a removable tamper evident strip that, whenremoved, provides access to the count sheet and visual indication thatthe count sheet holder has been compromised.
 6. The system of claim 2,wherein the fastener includes pressure sensitive adhesive applied to theoutwardly disposed face of the first sheet of material and the countsheet holder further includes a removable protective layer of materialdisposed on top of the pressure sensitive adhesive.
 7. The system ofclaim 1, wherein the perimeter of each of the first and second sheetsdefines four peripheral sides, and further wherein the first layer andsecond layer of material are joined about their periphery at three ofthe four sides.
 8. The system of claim 1, wherein the first sheet ofmaterial is at least partially transparent to permit the contents of thegenerally rectangular compartment to be viewed from outside the countsheet holder when the count sheet holder is mounted on the sterilizationwrap.
 9. The system of claim 3, wherein the count sheet holder includesindicia thereon to inform a user of the count sheet holder that thecount sheet is not to be considered to be sterile so as to avoidcontamination of the sterile field of an operating room.
 10. The systemof claim 1, wherein a peripheral edge of the second sheet of materialextends beyond the peripheral edge of the first sheet of material toform a foldable flap adapted and configured to be folded over theelongate opening, and further wherein the fastener is applied to anoutwardly disposed face of the second sheet of material.
 11. The systemof claim 1, wherein the count sheet holder further includes a zipperclosure disposed proximate the elongate opening for facilitating closureof the count sheet holder.
 12. A method of sterilizing surgicalinstruments in a hospital sterilization department, comprising: a)providing a sterilization tray defining at least one hole therethroughto permit a sterilant to pass therethrough and a plurality of sides,wherein the bottom and plurality of sides cooperate to define acompartment for receiving surgical instruments to be sterilized; b)disposing at least one surgical instrument in the sterilization tray; c)wrapping a sterilization wrap around the sterilization tray, thesterilization wrap being made from a breathable material adapted andconfigured to permit sterilant to pass through the wrap and through thetray; d) providing a count sheet including a listing describing the atleast one surgical instrument disposed in the sterilization tray; e)disposing a pouch-shaped count sheet holder on the sterilization wrap,the count sheet holder including: i) a first sheet of material; ii) asecond sheet of material disposed on and attached to the first sheet ofmaterial proximate the perimeter of the first and second sheets todefine an elongate opening proximate a peripheral edge of the firstsheet of material of the count sheet holder, wherein the opening is incommunication with a generally rectangular compartment defined betweenthe first and second sheets of material for receiving the count sheet;and iii) a fastener for attaching the count sheet holder to thesterilization wrap; f) disposing the count sheet in the count sheetholder to form a sterilization package; g) sterilizing the sterilizationpackage until the at least one surgical instrument is sterilized. 13.The method of claim 12, wherein the count sheet holder is disposed afterthe sterilization step.
 14. The method of claim 12, wherein the countsheet holder is reused in a subsequent sterilization operation.
 15. Asystem for hospital based sterilization of surgical instruments,comprising: a) a sterilization container having a bottom portion and atop portion, at least one of the bottom portion and the top portiondefining at least one hole therethrough to permit a sterilant to passtherethrough, wherein the bottom portion and top portion cooperate todefine an interior compartment for receiving surgical instruments to besterilized; b) at least one surgical instrument disposed in thesterilization container; c) a count sheet including a listing describingthe at least one surgical instrument disposed in the sterilizationcontainer; and d) a count sheet holder disposed on the sterilizationcontainer, the count sheet holder including: i) a cover portion; ii) abody portion; iii) a hinge attaching the cover portion to the bodyportion, wherein the body portion and cover portion cooperate to definea compartment for containing a count sheet when the cover is closed; andiv) a fastener for fastening the count sheet holder to the sterilizationcontainer.
 16. The system of claim 15, wherein the count sheet holderfurther includes at least one outwardly extending tab on at least one ofthe cover portion and body portion to facilitate opening or closure ofthe count sheet holder.
 17. The system of claim 16, wherein the countsheet holder further includes at least one vent to permit air or othergas to be evacuated from the compartment.
 18. The system of claim 16,wherein the count sheet holder includes an interlocking bead along twoparallel sides of the count sheet holder.
 19. The system of claim 15,wherein the sterilization container includes at least one handle orlatch and wherein the fastener of the count sheet holder includes astrap extending from the count sheet holder for attaching to the handleor latch of the sterilization container.
 20. The system of claim 19,wherein the strap includes a tip located at a distal end of the straphaving at least one barb for engaging an opening defined in the strap.21. The system of claim 20, wherein the opening is cross-shaped.
 22. Thesystem of claim 15, wherein the count sheet holder includes a snapclosure to maintain the count sheet holder in a closed condition. 23.The system of claim 15, wherein the count sheet holder is at leastpartially transparent to permit the contents of the count sheet holderto be viewed from outside the count sheet holder when the count sheetholder is mounted on the sterilization container.
 24. A method forsterilizing surgical instruments in a hospital, comprising: a) providinga sterilization container having a bottom portion and a top portion, atleast one of the bottom portion and the top portion defining at leastone opening to permit a sterilant to pass therethrough, wherein thebottom portion and top portion cooperate to define an interiorcompartment for receiving surgical instruments to be sterilized; b)disposing at least one surgical instrument in the sterilizationcontainer; c) providing a count sheet including a listing describing theat least one surgical instrument disposed in the sterilizationcontainer; d) disposing a count sheet holder on the outside of thesterilization container, the count sheet holder having a body portiondefining a compartment for containing a count sheet; e) disposing thecount sheet in the count sheet holder to form a sterilization package;f) sterilizing the sterilization package until the at least one surgicalinstrument is sterilized.
 25. The method of claim 24, wherein the countsheet holder further includes: a) a cover portion; and b) a fastener forfastening the count sheet holder to the sterilization container.
 26. Themethod of claim 24, wherein: a) the sterilization container includes atleast one handle; b) the fastener of the count sheet holder includes astrap extending from the count sheet holder for attaching to the handleof the sterilization container; and c) the disposing step includesdirecting the strap of the fastener of the count sheet holder around thehandle of the sterilization container to attach the count sheet holderto the sterilization container.
 27. The method of claim 24, wherein thebody of the count sheet holder includes an elongate tube closed on afirst end and open on the second end, and the count sheet holder furtherincludes: i) a cover portion adapted and configured to attach to thesecond end of the body portion; and ii) a fastener a for fastening thecount sheet holder to the sterilization container.
 28. The method ofclaim 25, wherein the count sheet holder further includes a hingeattaching the cover portion to the body portion, wherein the bodyportion and cover portion cooperate to define the compartment forcontaining a count sheet when the cover is closed.
 29. The method ofclaim 24, wherein disposing the count sheet in the count sheet holderincludes rolling the count sheet holder into a cylindrical shape priorto inserting the count sheet into the body portion of the count sheetholder.
 30. The method of claim 29, wherein disposing a count sheetholder on the outside of the sterilization container includes attachingthe count sheet holder to the container using a strap.